Synthetic Biologics Initiates Manufacturing Process for C. diff

Source: PharmaManufacturing.com

Jul 22, 2013

PRNewswire.com

Synthetic Biologics, Inc., a developer of biologics focused on the prevention and treatment of serious infectious diseases, announced today the initiation of the manufacturing process of the Company's proprietary beta-lactamase enzyme (SYN-004) to target the prevention of Clostridium difficile (C. difficile or C. diff) infections. 

Pursuant to an agreement with FUJIFILM Diosynth Biotechnologies UK Limited (Fujifilm), the initial phase of the SYN-004 manufacturing process is underway with the evaluation of beta-lactamase protein expression in Fujifilm's pAVEway™ platform. SYN-004 will be evaluated for production cell line yields as well as biological activity of the enzyme product.

"Initiating this expression platform evaluation with Fujifilm is an important first step in the SYN-004 manufacturing process. These efforts move us toward our goal of developing a prophylactic to prevent the devastating effects of C. diff infections, for which there is currently no vaccine or other approved preventive therapy," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Upon completion of production cell line evaluation and selection of the optimal expression clone, we intend to proceed rapidly with manufacturing of preclinical material for animal studies, and cGMP production of SYN-004 for clinical studies." Read more
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